(109 days)
No
The device description and performance studies focus on the physical characteristics, material, and mechanical performance of a dental implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a dental implant intended to support restorations, not for therapeutic treatment of a disease or condition.
No
Explanation: The device description states it is a dental implant made of titanium metal intended to be surgically placed in the bone. Its intended use is to support dental restorations, not to diagnose conditions.
No
The device description explicitly states it is a dental implant made of titanium metal, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system for surgical placement in the bone of the jaw. This is a surgical device used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a titanium dental implant, its design, and its surgical placement. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
The document describes a medical device used for surgical implantation, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The OneQ-SL s-Clean Implant System is in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The OneQ-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied by gamma sterilized that is same with almost all dental implant. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the Dentis dental implant system (K073486) of DENTIS Co., Ltd., and Dentis dental implant system(K150344) of DENTIS Co., Ltd. The difference between the subject and the predicate device are slightly different shape and surface treatment. This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344.
The OneQ-SL s-Clean Fixtures Internal Hex-connected, Bone level, submerged fixture, Tapered & Straight body Implant Fixture Dimension:
- Regular: Platform Diameters (Fixture Diameters) Ø3.7, Ø3.9, Ø4.2, Ø4.7, Ø5.2; Body Diameters Ø3.5, Ø3.6, Ø3.7, Ø4.2, Ø4.7; Lengths 7, 8, 10, 12, 14 mm
- Wide: Platform Diameters (Fixture Diameters) Ø6.0, Ø7.0, Ø8.0; Body Diameters Ø4.8, Ø5.8, Ø6.8; Lengths 7, 8, 10, 12 mm
The fixture and cover screw are made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae, upper and lower jaw arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests, including biocompatibility have been performed to ensure the device comply with the applicable International and US regulations.
Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the Dental Implant System (K150344) in s-Clean tapered Fixture and the angled abutment in support. Therefore, Submitted fatigue test report can be used as a proof of OneQ-SL c-Clean implant system.
Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The results of the above tests have met the standards, and demonstrated the substantial equivalence with the predicate device.
No clinical testing was performed for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K150344/K073486, K142313, K063216
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
Dentis Co., Ltd. c/o Ms. April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K153639
Trade/Device Name: OneQ-SL s-Clean Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 3, 2016 Received: March 11, 2016
Dear Ms. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Ms. April Lee
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153639
Device Name
OneQ-SL s-Clean Implant System
Indications for Use (Describe)
The OneQ-SL s-Clean Implant System is in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for DENTIS. The logo consists of an orange abstract shape on the left and the word "DENTIS" in black, bold letters on the right. The abstract shape is a curved shape with a circle at the top, resembling a stylized flame or drop.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
510(K) Summary
Submitter
Dentis Co., Ltd. Sun Chul Shin 99, Seongseoseo-ro, Dalseo-gu Daegu. 42718 South Korea Phone: +82-53-583-2804 Fax: +82-53-583-2806
Official Correspondent
Withus Group Inc. April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 909-274-9971 Fax: 909-460-8122
Device Information
Trade Name: OneQ-SL s-Clean Implant System Common Name: Endosseous Dental Implant Classification Name: Endosseous dental implant Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 4/7/2016
Description
The OneO-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied by gamma sterilized that is same with almost all dental implant. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the Dentis dental implant system (K073486) of DENTIS Co., Ltd., and Dentis dental implant system(K150344) of DENTIS Co., Ltd. The difference between the subject and the predicate device are slightly different shape and surface treatment. This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344.
The OneQ-SL s-Clean Implant system diameter and lengths are below:
- The OneQ-SL s-Clean Fixtures Internal Hex-connected, Bone level, submerged fixture, Tapered & Straight body Implant Fixture Dimension:
| Division | Platform Diameters
(Fixture Diameters) | Body Diameters | Lengths |
|----------|-------------------------------------------|----------------|---------------------|
| Regular | Ø3.7 | Ø3.5 | |
| | Ø3.9 | Ø3.6 | |
| | Ø4.2 | Ø3.7 | 7, 8, 10, 12, 14 mm |
| | Ø4.7 | Ø4.2 | |
| | Ø5.2 | Ø4.7 | |
| Wide | Ø6.0 | Ø4.8 | 7, 8, 10, 12 mm |
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Image /page/4/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a stylized flame or a curved shape with a circular element at the top. The overall impression is that of a company logo or brand mark.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
| Ø7.0 | Ø5.8 | |
|---|---|---|
| Ø8.0 | Ø6.8 |
The fixture and cover screw are made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.
Indications for Use
The OneO-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
5
Image /page/5/Picture/0 description: The image contains the word "DENTIS" in bold, sans-serif font. To the left of the word is an orange graphic. The graphic is a curved shape with a circle at the top.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate devices:
- K150344/K073486, Dentis Dental Implant System manufactured by Dentis Co., Ltd. ●
- K142313, OneQ-SL Implant System manufactured by Dentis. Co., Ltd. .
- K063216, Rescue Internal Dental Implant System by Megagen Co., Ltd. ●
| Division | Subject Device | Predicate | Predicate | Predicate | |
|---|---|---|---|---|---|
| Device Name | OneQ-SL s-Clean | ||||
| Implant System | Dentis Dental Implant | ||||
| System | Dentis Dental Implant | ||||
| System | OneQ-SL Implant System | Rescue Internal Dental | |||
| Implant System | |||||
| 510(k) Number | N/A | K073486 | K150344 | K142313 | K063216 |
| Manufacturer | DENTIS CO., LTD. | DENTIS CO., LTD. | DENTIS CO., LTD. | DENTIS CO., LTD. | MEGAGEN Co., Ltd. |
| Material | CP Titanium Gr.4 | CP Titanium Gr.4 | CP Titanium Gr.4 | CP Titanium Gr. 4 | CP Titanium Gr. 4 |
| Design | |||||
| (Fixture Type) | Image: Two implants |
- Internal Hex-connected
- Submerged Fixture
-Bone level - Tapered & straight
body - 3 sided cutting edge
with self-tapping | Image: Implant
-Internal Hex-
Connected
-Submerged Fixture
-Bone level, Tapered
body - 4 sided cutting edge
with self-tapping | Image: Implant
-Internal Hex-Connected
-Submerged Fixture
-Bone level, Tapered
body - 4 sided cutting edge
with self-tapping | Image: Two implants - Internal Octa-connected
- Non Submerged Fixture
- Tapered & straight body
- 3 sided cutting edge with
self-tapping | Image: Implant
-Internal Hex-connected
-Submerged Fixture
-Bone level, Straight
body
-4 sided cutting ecge
and self-tapping |
| Fixture Diameter | Regular: Ø 3.7, Ø 3.9,
Ø 4.2, Ø 4.7, Ø 5.2
Wide: Ø 6.0, Ø 7.0, Ø 8.0 | Ø 3.5, Ø 3.7, Ø 4.1, Ø
4.3, Ø 4.8, Ø 5.1, Ø
5.5, Ø 6.0, Ø 6.5, Ø
7.0 | Ø 3.7, Ø 4.1, Ø 4.3, Ø 4.8 | Regular(4.8 Platform):
Ø 3.7, Ø 4.2, Ø 4.7, Ø 5.2
Wide(6.5 Platform): Ø 4.7,
Ø 5.2, Ø 6.0, Ø 7.0 | Ø 6.0, Ø 6.5, Ø 7.0, Ø 8.0 |
| Fixture Length | Regular: 7, 8, 10 ,12, 14
mm
Wide: 7, 8, 10 ,12 mm | 7, 8, 9, 10, 12, 14 mm | 7, 8, 10, 12, 14 mm | Regular: 7, 8, 10, 12, 14mm
Wide(Ø4.7, Ø5.2): 7, 8,
10, 12, 14mm | 7.0~12.5mm |
| | | | | Wide( $\varnothing$ 6.0, $\varnothing$ 7.0): 7, 8, 10, 12mm | |
| Indication for use | The OneQ-SL s-Clean
Implant System is
indicated for use in
partially or fully
edentulous mandibles
and maxillae, in
support of single or
multiple unit
restorations including;
cemented retained,
screw retained, or
overdenture
restorations, and
terminal or
intermediate abutment
support for fixed
bridgework. This
system is dedicated for
one and two stage
surgical procedures.
This system is
intended for delayed
loading. | The Dentis Dental
Implant System is
indicated for use in
partially or fully
edentulous mandibles
and maxillae, in
support of single or
multiple-unit
restorations including;
cemented retained,
screw retained, or
overdenture
restorations, and
terminal or
intermediate abutment
support for fixed
bridgework. This
system is dedicated
for one and two stage
surgical procedures
and not dedicated for
immediate loading.
This system is
intended for delayed
loading. | The Dentis Dental
Implant System is an
endosseous dental
implant is indicated for
surgical placement in the
upper and lower jaw
arches, to provide a root
form means for single or
multiple-units prosthetic
appliance attachment to
restore a patient's
chewing function.
Implants can be placed
with a conventional two
stage surgical process
with an option for
transmucosal healing or
they can be placed in a
single stage surgical
process for immediate
loading. Immediate
loading is restricted to
the anterior mandible
based on four splinted
interforminal placed
implants. | The OneQ-SL Implant
System is indicated for use
in partially or fully
edentulous mandibles and
maxillae, in support of
single or multiple-unit
restorations including;
cemented retained, screw
retained, or overdenture
restorations, and terminal or
intermediate abutment
support for fixed
bridgework. This system is
intended for delayed
loading. | The Rescue Internal
Implant System is
intended to be surgically
placed in the maxillary
or mandibular molar
areas for the purpose
providing prosthetic
support for dental
restorations(Crown,
bridges and
overdentures) in
partially or fully
edentulous individuals.
These implants are
intended to be used
where smaller implants
have failed. |
| Surface
Treatment | SLA | RBM | RBM | SLA | RBM |
| Gamma
Sterilized | Yes | Yes | Yes | Yes | Yes |
| Product Code | DZE | DZE, NHA | DZE, NHA | DZE | DZE, NHA |
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Image /page/6/Picture/0 description: The image shows the logo for Dentis. The logo features an orange swirl design on the left side. To the right of the swirl is the word "DENTIS" in a bold, sans-serif font.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
7
Image /page/7/Picture/0 description: The image contains the logo for DENTIS. The logo features an orange abstract shape on the left, resembling a flame or a stylized leaf. To the right of the shape, the word "DENTIS" is written in bold, black capital letters. The overall design is simple and professional.
- Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
Substantial Equivalence Discussion
The OneQ-SL s-Clean Implant System has a substantially equivalent intended use as the identified predicates. The subject device is similar in fundamental scientific technology to the predicate device in that they all have been designed. manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant Abutments, and they are all constructed of titanium.
The subject and predicate devices are similar in indication for use, material, connection structure, packaging, function, using abutments, performance, design, technology and dimensions. The OneQ-SL s-Clean Implant system is compatible with abutment in s-Clean part of the Dentis Dental Implant System. This subject device is same with SLA surface treatment of OneQ-SL Implant System of the K142313 that have had same material, manufacturing process, packaging, sterilization condition and surface characteristic.
The differences between the subject device and predicate devices are fixture's diameters and similar thread shape.
The subject device platform diameters are Ø3.7, Ø3.9, Ø4.2, Ø4.7, Ø5.2, Ø6.0, Ø7.0 and Ø8.0. The predicate device platform diameters are Ø3.5, Ø3.7, Ø4.1, Ø 4.3, Ø4.8, Ø 5.1, Ø5.5, Ø6.0, Ø6.5, and Ø7.0 (K073486).
The predicate device platform diameters are Ø 3.7. Ø 5.2. Ø 6.0 and Ø 7.0. (K142313).
The subject device's thread is composed of double thread types and predicate device (K150344)'s threads are composed of micro thread and macro thread of buttress thread type. Reference predicate K063216 supports the substantial equivalence of the subject device's wide fixture with a diameter of 8.0mm.
This implant system has been subjected to several performance and product validations prior to release. Nonclinical tests, including biocompatibility have been performed to ensure the device comply with the applicable International and US regulations.
Differences in technological characteristics do not raise different questions compared to the predicate devices.
Non-Clinical Test Data
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Gamma Sterilization Validation Test performed in accordance with ISO11137-1
- Shelf life Validation Test performed in accordance with ISO 11607-1, -2, ASTM F1980-07 ●
- Biocompatibility tests performed in accordance with ISO 10993-1, ISO 10993-3, ISO 10993-5, ● ISO 10993-6, ISO 10993-10 and ISO 10993-11.
Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the Dental Implant System (K150344) in s-Clean tapered Fixture and the angled abutment in support. Therefore, Submitted fatigue test report can be used as a proof of OneQ-SL c-Clean implant system.
Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The results of the above tests have met the standards, and demonstrated the substantial equivalence with the predicate device.
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Image /page/8/Picture/0 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a curved check mark with a circle at the top. The graphic is gradient, with the color fading from dark orange to light orange.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.
Summary of clinical testing
No clinical testing was performed for this submission.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentis Co., Ltd. Concludes that the OneQ-SL s-Clean Implant System is substantially equivalent to the predicate devices as described herein.